New Swiss regs for homeopathic drugs
Swissmedic, the Swiss regulatory agency for drug and medicinal products, has issued details of the new procedures for the registration of homeopathic medicines in Switzerland. The regulation has been worked over several years and the final details were approved by Swissmedic's council late 2006.
The organization has now published detailed technical information on regulatory approval procedures. The new regime is highly differentiated and will take account of the variable risk factors.
The main features are that homeopathic drugs with a specific indication already require full regulatory approval and these arrangements do not change. In the case of homeopathic products without specific indications but based on known active principles (the so-called HAS list currently containing some 2,000 substances) a simple electronic reporting procedure has been introduced. Additional requirements apply for sterile preparations.
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